Ultomiris 300 mg/30 ml
Ultomiris 300 mg/30 ml is a medicine authorised by Swissmedic under authorisation number 67278. The authorisation holder is Alexion Pharma GmbH. The medicinal product code is Biotechnological medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 20 January 2020 and the authorisation is valid without a time limit. ATC code L04AJ02 places the medicine in the group Immunosuppressants.
| Authorisation number | 67278 |
|---|---|
| Name | Ultomiris 300 mg/30 ml |
| Full name | Ultomiris 300 mg/30 ml, Konzentrat zur Herstellung einer Infusionslösung |
| Authorisation holder | Alexion Pharma GmbH |
| Medicinal product code | Biotechnological medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | L04AJ02 |
| First authorisation | 20 January 2020 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Ultomiris 300 mg/30 ml, Konzentrat zur Herstellung einer Infusionslösung | A | 20 January 2020 |
| 2 | Ultomiris 300 mg/3 ml, Konzentrat zur Herstellung einer Infusionslösung | A | 16 September 2021 |
| 3 | Ultomiris 1100 mg/11 ml, Konzentrat zur Herstellung einer Infusionslösung | A | 16 September 2021 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 | Durchstechflasche(n) | L04AJ02 | 07.15.0. | A |
| 2 | 1 | Durchstechflasche(n) | L04AJ02 | 07.15.0. | A |
| 3 | 1 | Durchstechflasche(n) | L04AJ02 | 07.15.0. | A |
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Frequently asked questions
Is Ultomiris 300 mg/30 ml authorised in Switzerland?
Yes. Ultomiris 300 mg/30 ml is authorised by Swissmedic under authorisation number 67278, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Ultomiris 300 mg/30 ml have?
Ultomiris 300 mg/30 ml is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of Ultomiris 300 mg/30 ml?
The authorisation holder is Alexion Pharma GmbH. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.